CLOTH TENS/BNES ELECTRODE
FDA 510(k) clearance K942718 · decided 1994-09-22
Clearance details
- K-number
- K942718
- Device name
- CLOTH TENS/BNES ELECTRODE
- Applicant
- Conmed Andover Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-06-09
- Decision date
- 1994-09-22
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- GXY
- Device class
- 2
- Regulation number
- 882.1320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Haverhill, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Conmed Andover Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.